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Futura Medical PLC (FUM)

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Wednesday 10 April, 2019

Futura Medical PLC

Preliminary Results for the year ended 31 Dec 2018

RNS Number : 6825V
Futura Medical PLC
10 April 2019
 

 

 

THE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER ARTICLE 7 OF REGULATION (EU) NO 596/2014 OF THE MAR. UPON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN 

 

                                                                                                                                                       10 April 2019

 

 

Futura Medical plc

("Futura" or "the Company")

 

Preliminary Results for the year ended 31 December 2018

 

Sustained Progress made in 2018

 

Futura Medical plc (AIM: FUM), the pharmaceutical company developing a portfolio of innovative products for sexual health and pain, based on its proprietary, transdermal DermaSys® drug delivery technology is pleased to announce its preliminary results for the year ended 31 December 2018.

 

Highlights

 

Operational highlights

·    Following an extensive strategic review which was announced in September 2018, Futura has focused on maximising value in its development pipeline and product portfolio addressing two large market categories, sexual health and pain. The lead priorities are MED2005, its innovative topical treatment for erectile dysfunction (ED), and its pain portfolio including TPR100, a topical non-steroidal anti-inflammatory drug. Futura's core objectives are to:

−   complete the development of MED2005, currently in Phase 3 clinical trial, and

−   further realise value from the pain portfolio.

·    In February 2018, Angela Hildreth joined Futura in the role of Finance Director, Chief Operating Officer and Board Director.

 

 

MED2005 - Topical glyceryl trinitrate (GTN) formulation for erectile dysfunction

·       Publication of positive Phase 2a, "FM53" data, in peer-reviewed Journal of Sexual Medicine in February 2018.

·       First Phase 3 study, "FM57", commenced in October 2018.

·      Positive results from pharmacokinetic ("PK") study presented at the annual scientific meeting of the Sexual Medicine Society of North America (SMSNA) in November 2018, demonstrating safety and dose related absorption.

·      First advisory panel meeting held with US key opinion leaders (KOLs) at the SMSNA meeting in November 2018. KOL reaction to the therapeutic potential for MED2005 in erectile dysfunction and its areas of differentiation as well as the ongoing clinical programme was highly positive.

 

MED2005 - Post year end

·       Data presented at the European Society of Sexual Medicine (ESSM) congress in February 2019, including:

−   Positive Phase 2a and Pharmacokinetic data

−   In vitro impedance testing (concluded late 2018) which further supports the safety profile for male patients and their sexual partners.

·      Second advisory panel held at ESSM in February 2019 with prominent European KOLs to discuss data and the on-going development and educational programme. As with US KOL peers, physician reaction was very positive.

·      R&D event held in London in February 2019 including a presentation from Professor David Ralph, a world leading expert in erectile dysfunction and male infertility and Chair of the Futura Medical European Advisory Panel.

 

TPR100 - Topical non-steroidal anti-inflammatory for the pain and inflammation associated with sprains, strains and bruises and soft tissue rheumatism

·      Marketing authorisation application by UK commercialisation partner, Thornton & Ross (a subsidiary of STADA AG) submitted to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in July 2018.

·      Ongoing commercial discussions with several potential distribution partners for other territories. Any further licensing deals are expected to be after UK regulatory approval.

 

TPR100 - Post year end

·       Supporting Thornton & Ross on responses to initial MHRA feedback received in February 2019.

 

Financial highlights

·       £5.85 million raised in November 2018 to progress MED2005 through Phase 3 "FM57" study in erectile dysfunction.

·       £5.89 million net loss in the period (31 Dec 2017: net loss £3.90 million).

·       Cash resources of £9.16 million at 31 December 2018 (31 December 2017: £8.36 million).

 

James Barder, Chief Executive of Futura, commented: "2018 was a significant year of progress for Futura, with the commencement of enrolment of patients into our first Phase 3 trial with MED2005.  The trial is progressing as planned, and we look forward to Phase 3 headline data by end 2019.  During the year, in parallel to the clinical studies, our team has engaged with a number of eminent experts in the field of erectile dysfunction in both Europe and the US to discuss and gain valuable and positive feedback on the on-going development and educational programme for MED2005.

 

The funding secured in 2018 ensures that Futura has sufficient resources to complete and deliver the Phase 3 top line data by the end of 2019 - which the Board believes will be a major value inflection point for the Company."

 

Analyst meeting and webcast

 

The Executive Team will host a presentation at 10am (BST), 10 April 2019, for analysts at the office of N+1 Singer at 1 Bartholomew Lane, London EC2N 2AX.

 

Following the results meeting, a webcast of the presentation will also be made available within the Investor Centre section of the Futura company website at www.futuramedical.com.

 

For further information please contact:

Futura Medical plc 
James Barder, Chief Executive
Angela Hildreth, Finance Director and COO
Email: [email protected]
Tel: +44 (0) 1483 685 670

Nominated Adviser and Broker:

N+1 Singer
Aubrey Powell/ Ben Farrow (Corporate Finance)
Mia Gardner / Tom Salvesen (Corporate Broking)
Tel: +44 (0) 20 7496 3000

For media enquiries please contact:

Optimum Strategic Communications
Mary Clark/ Hollie Vile/ Ellie Blackwell
Email: [email protected]
Tel: +44 (0) 203 950 9144

 

Notes to Editors:

About Futura Medical plc

Futura Medical plc (AIM: FUM), is a pharmaceutical company developing a portfolio of innovative products based on its proprietary, transdermal DermaSys® drug delivery technology. These products are optimised for clinical efficacy, safety, administration and patient convenience and are developed for the prescription and consumer healthcare markets as appropriate. Current therapeutic areas are sexual health, including erectile dysfunction, and pain relief. Development and commercialisation strategies are designed to maximise product differentiation and value creation whilst minimising risk.

Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com

 

 

Chairman's Statement

 

2018 - a significant year for Futura Medical

Following an extensive strategic review which was announced in September 2018, Futura's strategy as an innovative R&D company, is to leverage its Dermasys® transdermal delivery technology to bring innovative products to market in sexual health and pain, bringing new treatment options to patients particularly in areas of significant unmet need. Erectile dysfunction (ED) is one such underserved area. It disrupts the lives of at least 1 in 5 men globally, affecting the sexual and emotional health of around 27 million men and their partners in the USA alone. There has been little innovation in ED treatments for over ten years and many patients continue to suffer dissatisfaction from existing treatments especially those looking for a fast acting treatment that can form part of sexual foreplay or those patients that are contraindicated from using existing therapies. Many patients do not just suffer from ED itself. They also suffer the debilitating toll it takes on quality of life, relationships and overall wellbeing for both themselves and their partners. Futura is therefore excited to be taking MED2005, its topical gel for ED through late stage clinical trials in order to make a significant difference in helping ED patients and their partners worldwide. With an independently assessed market potential of over $1 billion as a prescription treatment and subsequently over the counter (OTC) treatment, MED2005 is Futura's lead asset and a key value creation opportunity.

2018 was a busy year for execution. I would like to thank Futura's shareholders for their support and Futura's employees for their unstinting efforts in driving forward the progress of the Company, particularly the extensive preclinical and clinical development programme for MED2005, which requires an immense amount of detailed science, logistical and regulatory work, together with the outsourcing partners used as part of Futura's lean operating model. Futura has had dialogue with and taken the advice of industry stakeholders including potential licensing partners, US and EU regulators and leading experts in the field of sexual medicine, in designing the MED2005 clinical programme and we look forward to headline clinical data from the first Phase 3 "FM57" study by the end of 2019.

Finally, in February 2018, Derek Martin resigned from Futura and Angela Hildreth joined the Company as Finance Director and Chief Operating Officer. On behalf of the Board, I would like to reiterate our thanks to Derek for his contribution to the development of the Company during almost 10 years as Finance Director and to welcome Angela.

Robust governance and strategy

Governance and compliance continues to be a key focus for the Board. Board responsibilities, tasks and achievements for 2018 are described in detail in the Corporate Governance report of the 2018 Annual Report. The Board is focused on optimising Futura's strategies to capitalise on the Dermasys® transdermal technology product portfolio in sexual health and pain, in particular the opportunity for MED2005 in ED. The Board concentrates on ensuring management has the right resources and capabilities to succeed both now and in the future. Futura aims to be a source of new products for the consumer-oriented pharmaceutical and medical industries, in areas under-served by current treatment options and where innovation has stagnated to date.  We are confident that Futura will sustain the entrepreneurial and innovative culture it has created, as it moves its Dermasys® based products forward in development and commercialisation.

 

John Clarke

Chairman

Chief Executive's Review

As an innovative, specialist, R&D company it is our strategy to improve the lives of patients, particularly where they are dissatisfied with existing treatments. Meeting this objective goes hand in hand with value creation, which we seek to maximise by partnering at key inflection points. Our current focus is on sexual health and pain where we have found opportunities to leverage our Dermasys® technology to develop new products that solve clinically meaningful problems for patients. 

 

This year has been an important 12 months of progress for Futura. 2018 saw the Company undertake an extensive review of its pipeline and product portfolio and it was determined by the Board that a more concentrated R&D focus on MED2005, as well as its pain relief gels, will best enable us to achieve our aims.

 

MED2005 - topical glyceryl trinitrate (GTN) formulation for erectile dysfunction

 

Supportive pharmacokinetic clinical data

Throughout 2018, Futura has continued to generate additional, positive results from pharmacokinetic ("PK") studies with MED2005. Data, which was also presented in November at the annual scientific meeting of the Sexual Medicine Society of North America (SMSNA), give the Company confidence in the safety and potential efficacy of MED2005, including at the higher doses now being studied in Phase 3. They will add to and strengthen the data packages Futura intends to file with regulators when seeking approval.

 

In the recent PK study we demonstrated a dose related absorption profile and good bioavailability of glyceryl trinitrate (GTN) when administered at doses 0.2%, 0.4%, and 0.6% GTN. This supports the Company's strong belief that higher doses of MED2005 should improve efficacy. The acceptable tolerance profile of all dose forms of MED2005 tested also allowed inclusion of these three higher doses within the Phase 3 study.

 

MED2005 was shown to lead to a rapid rate of GTN absorption with first detection in blood plasma in 4-5 minutes, reaching peak levels in the bloodstream within 10-12 minutes for all doses. These findings are consistent with a product that has shown a rapid onset of action in the Phase 2a "FM53" study. It was shown that there is a low GTN residue on the penis at 5 minutes even with a high, 0.6% GTN MED2005 dose. This provides reassurance that there is likely to be minimal risk in transference of GTN to the sexual partner during intercourse, even at the higher doses. This finding also supports the side effect profile seen in the Phase 2a "FM53" study where only four, mild side effects were seen in sexual partners out of 1,003 sexual intercourse attempts. 

 

In February 2018, a peer reviewed paper was published in the Journal of Sexual Medicine detailing the Phase 2a, "FM53" study of MED2005 in ED. The study achieved its primary clinical endpoint and demonstrated efficacy, safety and a rapid speed of onset in a 0.2% GTN dose with MED2005. Positive outcomes were particularly promising in patients with mild and mild to moderate ED at this lowest dose of MED2005. We have confidence that the higher doses of 0.4% and 0.6% being studied in addition to the 0.2% dose in the first Phase 3 will show improved efficacy across patients with mild, mild to moderate and moderate ED.  This represents the large majority of ED sufferers throughout the world and the largest commercial opportunity.  Severe ED patients, who often have the most medical complications as well as being the oldest men, are a difficult patient cohort to treat.  This is further evidenced by the limited success of the existing ED treatments.  We therefore remain cautious over the potential benefit MED2005 will bring to severe patients.  The first Phase 3 study will include patients of all ED severities as was the case in the Phase 2a study FM53, the analysis of the primary endpoints will pool data across mild, moderate and severe ED. Therefore if reduced efficacy in severe ED patients occurs, it is not expected to compromise the overall success of the study.

 

The publication of the Phase 2a clinical data in the leading, peer-reviewed scientific Journal of Sexual Medicine underlines the robustness of our previously reported study and demonstrates the level of scientific interest in MED2005.

 

MED2005 Phase 3 clinical programme underway

MED2005's first Phase 3 study, "FM57" commenced in October 2018. The study protocol has incorporated the Company's learnings from FM53, feedback received from potential commercial partners and also US and European regulatory agencies to optimise the commercial value as well as maximise the chances of clinical success and thereby regulatory approval.

 

This 1,000 patient study for the treatment of mild, moderate or severe ED includes approximately 60 centres across Central and Eastern Europe to ensure patients are recruited as quickly and efficiently as possible. Regulatory and ethics clearance to conduct FM57 has been received across all nine countries and the target of headline data by the end of 2019 remains on track.

 

Planning for a second, confirmatory Phase 3 study for MED2005 has been undertaken, again after extensive dialogue with regulators and our KOLs in the field of ED. This study will incorporate a US patient cohort which is expected to enable regulatory filing in the USA. This study is expected to be informed by the first Phase 3 and therefore start after end of the first Phase 3 study. We believe MED2005 has the required efficacy, speed of onset and favourable safety profile consistent with use as a prescription therapy as well as the potential to be an over-the-counter therapy as well.

 

Discussions continue with a number of interested commercial partners for the out-licensing of MED2005 although the Company's main focus is to deliver Phase 3 headline data by the end of 2019 to facilitate these ongoing discussions.

 

MED2005 safety profile in female partners

At the European Society of Sexual Medicine (ESSM) congress in Slovenia, 14-16 February 2019, Futura presented data which indicates that MED2005 will have a favourable safety profile in female partners. These data included observational data from the Phase 2a study where only four adverse events were noted in females out of over 1,000 intercourse events; penile swabbing data obtained from the PK Study which indicated that very low amounts of MED2005 remain on the penis after five minutes; and supporting evidence regarding the topical safety of MED2005, based on in vitro impedance testing concluded in late 2018. Results from the latter showed no significant difference in impedance between MED2005 and two commercially available lubricants used for sexual intercourse. These data is strongly suggestive that there is likely to be no increased risk of sexually transmitted infections being transferred to sexual partners, as a result of disruption to local tissue, when using MED2005 compared to the two lubricants also tested.

 

Education and outreach on erectile dysfunction and MED2005

Futura held its first advisory panel meeting with US experts at the SMSNA meeting in November 2018. The advisory panel were unanimous in their view that there has been little recent credible innovation in the treatment of ED and were therefore excited by the PK and Phase 2a "FM53" findings presented, which demonstrate the potential of MED2005 as both a topical and fast-acting erectile dysfunction treatment, key differentiators to other ED products on the market.

 

On 11 February 2019, Futura held a Research & Development Day in London for analysts and institutional investors. The event was well received with positive feedback and provided an opportunity to hear first-hand from Professor David Ralph, a prominent world leading expert in erectile dysfunction and male infertility and Chair of the Futura Medical European advisory panel, on the significant negative effect ED has on the quality of life, relationships and overall wellbeing of ED patients and their partners. The event also provided an opportunity for the Futura team to describe the Company's R&D strategy with a focus on its DermaSys® drug delivery technology and lead product MED2005's robust and extensive development programme. A webcast of the event is available on the Futura website.

 

Following the successful US advisory panel meeting at SMSNA in November 2018, a second advisory panel was held at ESSM in February 2019 to discuss MED2005 data and the on-going development and educational programme for MED2005 with prominent European KOLs. We were delighted that the feedback of this second EU advisory meeting very much echoed the sentiment and excitement seen at the first US advisory meeting.  Further meetings are planned to update and increase awareness of the potential innovation that MED2005 brings within the treatment arena of ED.

 

TPR100 - topical non-steroidal anti-inflammatory for the pain and inflammation associated with sprains, strains and bruises and soft tissue rheumatism

In July 2018, Thornton & Ross, a subsidiary of STADA AG, Futura's UK commercialisation partner for TPR100, filed a marketing authorisation application for the product with the UK Medicines and Healthcare products Regulatory Agency (MHRA). In February 2019, the MHRA responded with some questions requiring some additional laboratory studies which are in the process of being conducted in order to address the MHRA's questions and allow the submission to progress and complete the review process. Futura has ongoing commercial discussions with several potential distribution partners for territories outside of the UK. Finalisation of such regional licensing deals is expected to be after UK regulatory approval.

 

Corporate & Financial

In February 2018, Angela Hildreth joined Futura in the role of Finance Director, Chief Operating Officer and Board Director adding further experience to the executive team gained in financial, operational and strategic roles in healthcare and other industries and including the AIM market and development-stage companies.

Outlook

Futura is now in a position to build value by progressing the development of MED2005 through its planned Phase 3 studies and we look forward to headline data towards the end of 2019 after which we will examine the possibility of an accelerated European filing strategy depending on the strength of the data, including at the higher GTN doses for MED2005. We are excited to be moving closer to bringing an innovative, highly differentiated ED product to market that could help the many ED patients whose needs are not met by current treatments.

 

James Barder

Chief Executive

 

 

 

Financial Review

 

As outlined in the Chief Executive Officer's Statement, during the year, we continued to focus our financial resources on the development programme for our lead asset MED2005.  Spend on research and development activities continued to grow with other central and administration costs remaining broadly the same as the prior year.  November 2018 also saw gross funds raised of £5.85 million through the combination of subscription for shares through PrimaryBid and the Open Offer; and institutional placing.

 

 

Research and development expenditure

In July 2018 we commenced the first MED2005 "FM57" Phase 3 study across approximately 60 centres in Central and Eastern Europe with patients commencing recruitment in October 2018.  FM57 costs together with additional costs relating to completion of the FM58 PK Study earlier in the year, and expected manufacturing stability and validation activities resulted in research and development expenses increasing by £1.9 million to £6.0 million for 2018 (2017: £4.1 million) which were in line with expectations.

 

Following the strategic review in the year, there has also been a focus on the reduction in costs relating to CSD500, an erectogenic condom, with limited costs relating to CSD500 expected in 2019.

 

There was no capitalisation of any Research and Development costs in 2018. 

 

Administrative expenses

General and administration expenses increased slightly to £1.23 million (2017: £1.12 million). This reflects the continued focus on tight control of central costs with research and development activities out-sourced when required.

 

Revenue

No revenue was recorded in the year. The Company resolved to focus its financial and human resources on late stage clinical development of its lead asset MED2005 to accelerate progress towards achieving a significant, continuous revenue stream within a few years. 

 

Tax

It is expected that an R&D Tax Credit of £1.36 million will be claimed in respect of 2018 and the cash refund is expected to be received in the second half of 2019 from HMRC.

 

Loss per share

The basic loss per share for 2018 was £4.46 (2017: £3.23). Details of the loss per share calculations are provided in Note 11 to the accounts.

 

Cash Balance

Cash balance at the end of 2018 was £9.16 million (2017: £8.36 million).  Cash burn during the year was £5.63 million (2017: £5.02 million) primarily in relation to MED2005 research and development activities.  Net funding of £5.48 million was raised in the year, resulting in a net cash inflow of £0.80 million.  Futura is fully funded to deliver the top line data from the first Phase 3 study and will manage its funding strategy appropriately to what is expected to be a material inflection point for the Company.

Consolidated Statement of Comprehensive Income

For the year ended 31 December 2018

 

 

Year ended

31 December

             2018

Year ended

31 December

             2017

 

Notes

                  £

                  £

Revenue

2,5

-

           362,727

Research and development costs

 

(6,038,941)

(4,100,453)

Administrative costs

 

(1,227,547)

(1,118,218)

Operating loss

6

(7,266,488)

(4,855,944)

Finance income

9

         27,576

            19,316

Loss before tax

 

(7,238,912)

(4,836,628)

Taxation recoverable    

10

1,358,336

           936,344

Loss for the year being total comprehensive loss attributable to owners of the parent company

 

 

 

(5,880,576)

 

(3,900,284)

 

 

 

 

Basic and diluted loss per share (pence)

11

(4.46 pence)

(3.23 pence)

 

 

Consolidated Statement of Changes in Equity

For the year ended 31 December 2018

 

 

 

 

Share

 Capital

Share

Premium

Merger

 Reserve

    Retained

Losses

 Total

   Equity

 

Notes

                £

                 £

               £

                  £

                 £

At 1 January 2017

 

     240,290

      44,451,745

   1,152,165

   (33,260,172)

      12,584,028

Total comprehensive loss for the year

 

              

               -

                

                    -

           

               -

 

    (3,900,284)

  

   (3,900,284)

Share-based payment

19

         -

                      -

                -

          201,261

           201,261

Shares issued during the year

18

         1,102

            219,651

                -

                    -

           220,753

At 31 December 2017

 

    241,392

      44,671,396

   1,152,165

   (36,959,195)

        9,105,758

Total comprehensive loss for the year

 

              

               -

                

                    -

           

               -

 

        (5,880,576)

  

   (5,880,576)

Share-based payment

19

         -

                      -

                -

         146,833

           146,833

Shares issued during the year

18

     167,775

        5,312,464

                -

                    -

        5,480,239

At 31 December 2018

 

    409,167

      49,983,860

   1,152,165

    (42,692,938)

       8,852,254

 

 

Merger reserve represents the reserve arising on the acquisition of Futura Medical Developments Limited in 2001 via a share for share exchange accounted for as a group reconstruction previously using merger accounting under UK GAAP.

 

Retained losses represent all other net gains and losses not recognised elsewhere.

 

Share premium represents amounts subscribed for share capital in excess of nominal value, less the related costs of share issues.

 

Consolidated Statement of Financial Position

As at 31 December 2018

 

 

As at

31 December

         2018

As at

31 December

         2017

 

Notes

              £

              £

Assets

 

 

 

Non-current assets

 

 

 

Plant and equipment

12

47,473

63,517

Total non-current assets

 

47,473

63,517

 

 

 

 

Current assets

 

 

 

Inventories

13

7,780

70,413

Trade and other receivables

15

306,408

181,076

Taxation Recoverable

10

1,358,192

927,247

Cash and cash equivalents

16

9,157,916

8,362,646

Total current assets

 

10,830,296

9,541,382

 

 

 

 

Liabilities

 

 

 

Current liabilities

 

 

 

Trade and other payables

17

(2,025,515)

(499,141)

Total liabilities

 

(2,025,515)

(499,141)

Total net assets/(liabilities)

 

8,852,254

9,105,758

 

 

 

 

Capital and reserves attributable to

owners of the parent company

 

 

 

Share capital

18

409,167

241,392

Share premium

 

49,983,860

44,671,396

Merger reserve

 

1,152,165

1,152,165

Retained losses

 

(42,692,938)

(36,959,195)

Total equity

 

  8,852,254

9,105,758

 

Consolidated Statement of Cash Flows

For the year ended 31 December 2018

 

 

 

Notes

 Year ended

   31 December

              2018

 Year ended

   31 December

              2017

 

 

 

£

£

 

Cash flows from operating activities

 

 

 

 

Loss before tax

 

       (7,238,912)

       (4,836,628)

 

Adjustments for:

 

 

 

 

Depreciation

  12

            19,850

            13,428

 

Loss on disposal of fixed assets

 

703

-

 

Finance income

    9

           (27,576)

           (19,316)

 

Share-based payment charge

  19

            146,833

            201,261

 

Cash flows from operating activities before changes in working capital

  

       (7,099,102)

       (4,641,255)

 

 

  

 

 

 

Decrease in inventories

  13

62,633

13,228

 

(Increase) / decrease in trade and other receivables

 

          (125,332) 

            (42,087)

 

(Decrease) / increase in trade and other payables

  17

       1,526,375

    (356,036)

 

Cash used in operations

  

       (5,635,426)

       (5,026,150)

 

 

  

 

 

 

Income tax received

  

           927,391

           851,343

 

Net cash used in operating activities

  

       (4,708,035)

       (4,174,807)

 

 

  

 

 

 

Cash flows from investing activities

  

 

 

 

Purchase of plant and equipment

 12

             (4,510)

            (55,594)

 

Interest received

  

             27,576

             19,316

 

Cash generated by/(used in) investing activities

  

            23,066

            (36,278)

 

 

  

 

 

 

Cash flows from financing activities

  

 

 

 

Issue of ordinary shares

    18

      5,943,421

      220,753

 

Expenses paid in connection with share issue

 

       (463,182)

                  -

 

Cash generated by financing activities

  

       5,480,239

       220,753

 

 

  

 

 

 

(Decrease) / increase in cash and cash equivalents

 

            795,270

   (3,990,332)

 

Cash and cash equivalents at beginning of year

 

    8,362,646

  12,352,978

 

Cash and cash equivalents at end of year

16

   9,157,916 

   8,362,646 

 

 

 

Notes (continued)

For the year ended 31 December 2018

1.  Corporate Information

 

Futura Medical plc (the "Company") is a public limited company incorporated and domiciled in the United Kingdom and whose shares are publicly traded on the AIM Market of the London Stock Exchange.  The registered office is located at Surrey Technology Centre, 40 Occam Road, Guildford, Surrey, GU2 7YG.

 

These Group financial statements consolidate those of the Company and its subsidiaries (together referred to as "the Group" and individually as "Group entities") for the year ended 31 December 2018.

 

The consolidated financial statements of the Company and the Group for the year ended 31 December 2018 were authorised for issue by the Board of Directors on 09 April 2019.

 

The Group is principally engaged in the development of pharmaceutical and healthcare products.

 

2.  Accounting policies

 

         2.1 Basis of preparation

 

The Group's statutory accounts have been audited for the year ended 31 December 2018 and though the audit opinion was unmodified the auditor drew attention to a material uncertainty related to going concern. This material uncertainty was in relation to the Group's ability to access additional sources of finance which may be dependent upon the outcome of the MED2005 trial.

 

The consolidated financial statements have been prepared on a going concern basis and under the historical cost convention and have been prepared and approved by the Directors in accordance with International Financial Reporting Standards ("IFRSs") as adopted by the European Union. The principal accounting policies applied in the preparation of the consolidated financial information are set out below.  These policies have been consistently applied to all years presented, unless otherwise stated.

 

The consolidated financial statements are presented in sterling.

 

         2.2 Going Concern

 

The financial statements have been prepared on a going concern basis after considering the year end cash position and reviewing budgets and cash flow forecasts for the foreseeable future which covers a period of at least 12 months from the date of approval of these financial statements. The Group has reported a loss after tax for the year of £5,880,576 (2017: £3,900.284). The Group has net current assets at 31 December 2018 of £8,804,780 (2017: £9,042,241).

 

The Directors have prepared a detailed forecast for a period of three years from 31 December 2018 based on current plans.  The forecast assumes both committed costs and future planned discretionary

2. Accounting policies (continued)

 

spend and the Directors consider that they will have sufficient cash resources to settle all committed costs and discretionary costs for at least 12 months from the date of approval of these financial statements. The forecasts also assume that the group will be able to raise additional sources of finance to fund future expenditure if the results of the MED2005 trial are positive.

 

It should be noted that the forecasts do not include any cash receipts from future MED2005 out-licensing agreements or other forms of funding that the Directors are actively considering, and which the Directors believe, from previous and ongoing discussions will result in material cashflow into the business during the detailed forecast period of three years from 31 December 2018.  

 

The Directors continue to monitor the levels of discretionary spend and have the ability to delay certain costs, such as Research and Development expenditure, in the event of unforeseen cash constraints or delayed cash receipts.

 

The Directors have also considered a scenario where the phase 3 results of the MED2005 trial are not successful, although this scenario is considered to be highly unlikely. In this scenario the Directors will have sufficient cash to meet and settle all the committed expenditure and have sufficient cash to re-align their business strategy and continue investment in other products within their pipeline.  The cash balances will be sufficient to cover at least 12 months from the date of signing the financial statements.

 

The Directors, having reviewed the Group's and Company's budgets and plans, taking account of reasonably possible changes in trading performance, have a reasonable expectation that the Group and the Company have adequate resources to continue in operational existence for the foreseeable future (being at least 12 months from the date of approval of these financial statements) and that it is therefore appropriate to continue to adopt the going concern basis in preparing the financial statements.

 

Based on the above, the Directors believe that it remains appropriate to prepare the financial statements on a going concern basis.  However, they acknowledge there exists a material uncertainty over the Group's ability to access additional sources of finance which may be dependent upon the outcome of the MED2005 trial - that may cast significant doubt on the Group's and Company's ability to continue as a going concern and, therefore, to continue realising its assets and discharging its liabilities in the normal course of business.  The financial statements do not include any adjustments that would result from the basis of preparation being inappropriate.

 

         2.3 Standards, amendments and interpretation to existing standards

 

The Directors have considered all new standards, amendments to standards and interpretations which are mandatory for the first time for the financial year beginning 1 January 2018. From 1 January 2018 the Group adopted IFRS 15 Revenue from Contracts with Customers. The Group has also adopted

 

2.  Accounting policies (continued)

 

IFRS 9 Financial Instruments. There are no other new or amended standards which impact the Group in the period.

The Group is continuing to assess the impact of IFRS 16 Leases.  The Group has currently only engaged in short term leases which are outside the scope of IFRS 16 and therefore the Directors do not expect the adoption of IFRS 16 to have a material impact on the Group's consolidated statements.

 

IFRS 15 Revenue from Contracts with Customers

 

IFRS 15 Revenue from contracts with customers deals with revenue recognition and establishes principles for reporting useful information to users of financial statements.  The standard replaces IAS 18 Revenue.

Given the limited revenue in the periods prior to the transition and therefore minimal impact on the adoption of the standard on the accounts and, therefore on the users of the financial statements, the Group has elected to use the cumulative method meaning if applicable, comparative prior years would not be restated rather the cumulative effect of applying the new standard prior to periods to 31 December 2017 is recognised in the opening balance of retained earnings as at 1 January 2018.  No adjustments have been required as a consequence of these standards' adoption, as the impact is immaterial.

 

IFRS 9 Financial Instruments

In the current period the Group has applied IFRS 9 Financial Instruments and no adjustments have been required as a consequence of these standards' adoption, as the impact is immaterial.

 

2.4 Revenue

IFRS 15 had no material impact on the financial statements of the group in the period as no revenue was generated.  In the prior year, revenue was generated from non-refundable milestone payments and royalty income.

Non-refundable milestone payments from right-to-use licences is usually recognised at the point in time that the performance condition is satisfied which is when the licence agreement is signed by both parties as this is the date the customer can begin to use and benefit from the licence unless there is an expectation that the IP licensed requires further substantial work and whether the customer would benefit from and have access to such further work.  If the licence allows the customer to be provided with access to IP which is expected to change over time, this implies control is transferred over time and therefore revenue would be recognised over time.  If the IP is not expected to significantly change then control is transferred at a point in time and revenue will be recognised at the point the IP is transferred to the customer.  The milestone payments received in the prior year were recognised when the licence was signed by both parties as there were no further performance conditions to satisfy and the IP was not expected to change.

 

2.  Accounting policies (continued)

 

Royalty income relating to the sale by a licencee of licenced product is recognised in revenue when the     title of goods is transferred to the licencee.

 

2.5 Leased assets

Leases, which contain terms whereby the Group does not assume substantially all the risks and rewards incidental to ownership of the leased item are classified as operating leases. Operating lease rentals are charged to the Consolidated Statement of Comprehensive Income on a straight-line basis over the lease term. The Group does not hold any assets under finance leases.

 

 

2.6 Intangible assets

Research and development ("R&D")

Expenditure incurred on the development of internally generated products is capitalised if it can be demonstrated that:

 

●     it is technically feasible to develop the product for it to be sold;

    adequate resources are available to complete the development;

    there is an intention to complete and sell the product;

    the Group is able to out-license or sell the product;

    sale of the product will generate future economic benefits; and

     expenditure on the project can be measured reliably.

 

Capitalised development costs, including patents and trademarks, are amortised over the periods in which the Group expects to benefit from selling the products developed but not exceeding five years. The amortisation expense is included in R&D costs recognised in the Consolidated Statement of Comprehensive Income. The useful life and the value of the capitalised development cost are assessed for indicators of impairment at least annually. The value is written down immediately if impairment has occurred and the unimpaired cost amortised over the reduced useful life.

 

The Directors consider that the criteria to capitalise development expenditure are not yet met for CSD500 as the product has not yet commercially launched in at least one major market therefore commercial feasibility of the product is not yet certain.  Currently no other products in development have been approved.

 

Development expenditure, not satisfying the above criteria, and expenditure on the research phase of internal projects are included in R&D costs recognised in the Consolidated Statement of Comprehensive Income as incurred.

 

 

 

2.  Accounting policies (continued)

 

2.7 Plant and equipment

Plant and equipment is initially recognised at cost, and subsequently at cost less accumulated depreciation and any accumulated impairment losses. Cost includes expenditure that is directly attributable to the acquisition of the items. Depreciation is charged to the Consolidated Statement of Comprehensive Income at rates calculated to write off the cost, less estimated residual value, of each asset on a straight-line basis over their estimated useful lives.

Computer equipment                             2 - 5 years straight line

               Fixtures and fittings                               3 - 10 years straight line

The assets' residual values and useful lives are determined by the Directors and reviewed and adjusted, if appropriate, at each Consolidated Statement of Financial Position date.

 

2.8 Impairment of non-financial assets

An impairment review is carried out for assets being amortised or depreciated when a change in market conditions and other circumstances indicate that the carrying value may not be recoverable.  The recoverable amount is the higher of an asset's fair value less costs to sell and value-in-use.  For the purpose of assessing impairment, assets are grouped at the lowest levels for which they are separately identifiable cashflows.

 

2.9 Inventories

Inventories are consumable materials to be used in development and are initially recognised at cost, and subsequently at the lower of cost and net realisable value. Cost includes materials, related contract manufacturing costs and other direct costs. Cost is calculated using the first in, first out method. Net realisable value is based on estimated selling price, less further costs expected to be incurred to completion and disposal.

 

A provision is recognised immediately in the Consolidated Statement of Comprehensive Income in respect of obsolete or defective items, where appropriate.

 

2.10 Financial instruments

IFRS 9 sets out requirements for measuring and recognising financial assets, financial liabilities and some contracts to buy or sell non-financial items.  This standard replaces IAS 39 Financial Instruments and Measurement and has not had a material impact on the consolidated financial statements.  Financial instruments comprise trade and other receivables, cash at bank and in hand, restricted cash, loans and borrowings, and trade and other payables.

 

Trade and Other receivables

Trade and other receivables are recognised initially at fair value.  Subsequent to initial recognition they are measured at amortised cost using the effective interest method, less any impairment losses.

 

2.  Accounting policies (continued)

 

Trade payables, other payables and other liabilities

Trade and other payables are recognised initially at fair value.  Subsequent to initial recognition they are measured at amortised cost using the effective interest method, less any impairment losses.  The Group de-recognises financial liabilities when the Group's obligations are discharged, cancelled or expired.

 

Cash and cash equivalents

Cash and cash equivalents comprise cash balances in the bank and short-term money market fund deposits.

 

2.11 Taxation

Income tax is recognised or provided at amounts expected to be recovered or to be paid using the tax rates and tax laws that have been enacted or substantively enacted at the Consolidated Statement of Financial Position date. R&D tax credits are recognised on an accruals basis and are included as an income tax credit under current assets.

 

Deferred tax assets and liabilities are recognised where the carrying amount of an asset or liability on the Consolidated Statement of Financial Position date differs from its tax base, except for differences arising on:

 

·      the initial recognition of an asset or liability in a transaction which is not a business combination and which at the time of the transaction affects neither accounting profit nor taxable profit; and

 

·      investments in subsidiaries and jointly controlled entities where the Group is able to control the timing of the reversal of the difference and it is probable that the difference will not reverse in the foreseeable future.

 

 

Recognition of deferred tax assets is restricted to those instances where it is probable that taxable profits will be available against which the difference can be utilised.

 

The amount of the asset or liability is determined using tax rates that have been enacted or substantively enacted by the Consolidated Statement of Financial Position date and are expected to apply when the deferred tax liabilities/(assets) are settled/(recovered). Deferred tax balances are not discounted.

 

Deferred tax assets and liabilities are offset when the Group has a legally enforceable right to offset current tax assets and liabilities and the deferred tax assets and liabilities relate to taxes levied by the same tax authority on either:

 

·      the same taxable group company; or

 

 

2.  Accounting policies (continued)

 

·      different group entities which intend to settle current tax assets and liabilities on a net basis, or to realise the assets and settle the liabilities simultaneously, on each future period in which significant amounts of deferred tax assets or liabilities are expected to be settled or recovered.

 

2.12 Foreign currency translation

Foreign currency transactions are translated into the functional currency using the exchange rates prevailing at the dates of the transactions. Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation at period end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognised in the Consolidated Statement of Comprehensive Income in the period in which they arise.

        

2.13 Employee benefits

Defined contribution plans

The Group provides retirement benefits to all employees who wish to participate in defined contribution pension schemes. The assets of these schemes are held separately from those of the Group in independently administered funds. Contributions made by the Group are charged to the Consolidated Statement of Comprehensive Income in the period in which they become payable.

 

Accrued holiday pay

Provision is made at each Consolidated Statement of Financial Position date for holidays accrued but not taken, at applicable rates of salary. The expected cost of compensated short-term absence (holidays) is charged to the Consolidated Statement of Comprehensive Income on an accruals basis.

    

Share-based payment transactions

The Group operates an equity-settled share-based compensation plan. For all share options awarded to employees, and others providing similar services, the fair value of the share options at the date of grant is charged to the Consolidated Statement of Comprehensive Income over the vesting period. Non-market vesting conditions are taken into account by adjusting the number of equity instruments expected to vest at each Consolidated Statement of Financial Position date so that, ultimately, the cumulative amount recognised over the vesting period is based on the number of share options that eventually vest. There are no market vesting conditions. If the terms and conditions of share options are modified before they vest, the change in the fair value of the share options, measured immediately before and after the modification, is also charged to the Consolidated Statement of Comprehensive Income over the remaining vesting period. The proceeds received when share options are exercised, net of any directly attributable transaction costs, are credited to share capital (nominal value) and the remaining balance to share premium. All employee share option holders enter into an HM Revenue & Customs joint election to transfer the employers' national insurance contribution potential liability to the employee, therefore no Group asset or liability arises.

 

2.  Accounting policies (continued)

 

Long-term incentive plan

The Group operates a long-term incentive plan for all staff and Directors. The quantum of any awards receivable will depend on the Group achieving set milestones and the share price at the time relative to targets set in advance. The Group can exercise discretion in settling any award in equity or in cash.

 

2.14 Finance income

Interest income is recognised on a time-proportion basis using the effective interest rate method.

 

3.  Critical accounting judgements, assumptions and estimates

 

The preparation of the consolidated financial statements in conformity with IFRS requires management to make certain estimates, assumptions and judgements that affect the application of accounting policies and the reported amounts of assets and liabilities and the reported amounts of income and expenses in the year.

 

Critical accounting estimates, assumptions and judgements are continually evaluated by the Directors based on available information and experience. As the use of estimates is inherent in financial reporting actual results could differ from these estimates. No significant estimates were identified during the year. Other estimates are disclosed below.

 

3.1 Estimates and assumptions

 

Share-based payments

The Group operates an equity-settled share-based compensation plan for employee (and consultant) services to be received and the corresponding increases in equity are measured by reference to the fair value of the equity instruments as at the date of grant. The fair value determination is based on the principles of the Black-Scholes Model which uses an input of volatility based on historical data. Historical volatility may not be indicative of future volatility, yet the Directors judge this to be the most appropriate method of calculation. Given the share option expense of £146,833 (2017: £201,261), the volatility methodology used is not expected to have a material impact on these financial statements. Details of the fair value calculation for options granted during the year, including other inputs into the Black Scholes model, are disclosed in Note 19.

 

3.2 Judgements

Deferred tax recognition

The determination of probable future profits, against which the Group's deferred tax profits can be offset, requires judgement.  To date no deferred tax assets have been recognised.

 

 

 

 

R&D Tax Credits

The current tax receivable as disclosed in Note 9, represents an R&D tax credit based on an advance claim with HMRC.  The final receivable is subject to the correct application of complex R&D rules and HMRC approval.  Historically, claims have been successful and the Group expects the current year to be successful too.

 

4.     Financial Risk

 

4.1 Financial risk factors

The Group's activities expose it to a variety of financial risks: market risk (including foreign exchange rate risk, cash flow interest rate risk and fair value interest rate risk); credit risk and liquidity risk. 

It is Group policy not to enter into speculative positions using complex financial instruments.

 

(i) Market risk

Foreign exchange rate risk

The Group primarily enters into supplier contracts which are to be settled in sterling. However, some contracts involve other currencies including the US dollar and the euro. The Group may use forward exchange contracts as an economic hedge against currency risk, where cashflow can be judged with reasonable certainty.  There were no open forward contracts as at 31 December 2018 or at 31 December 2017 and the Group did not enter into any such contracts during 2018 nor 2017.

        

At 31 December 2018 the Group had trade payables denominated in a foreign currency totalling £931,532 (31 December 2017: £11,582).

 

Cash flow interest rate risk and fair value interest rate risk

The Group's interest rate risk arises from short-term money market deposits.

 

(ii) Credit risk

Credit risk arises from cash and cash equivalents and money market deposits as well as credit exposure in relation to outstanding receivables.  The exposure relating to outstanding receivables is immaterial and the carrying amount of cash balances is as follows:

 

31 December

         2018

31 December

         2017

 

              £

              £

 Cash at bank and in hand

5,706,519

168,825

Sterling short-term money market funds

3,451,397

8,193,821

 

9,157,916

8,362,646

 

The Directors consider the Group's exposure to credit risk to be acceptable and normal for a similar entity at its stage in development.

 

 

 

 

4.    Financial Risk (continued)

 (iii) Liquidity risk

The Group's approach to managing liquidity is to ensure that, as far as possible, it will always have sufficient liquidity to meet its liabilities when due, under both normal and stressed conditions, without incurring losses or risking damage to the Group's reputation.

 

The Group manages all of its external bank accounts centrally and in accordance with defined treasury policies.  The policies include a minimum acceptable credit rating of relationship bank accounts and financial transaction authority limits.  Any material change to the Group's principal bank facility requires Board approval. 

 

4.2 Capital risk management

The Group's policy is to maintain a strong capital base.  The Group does not yet have significant recurring revenues and has mainly financed its operations through the issue of new shares and management of working capital.  The Group's capital resources are managed to ensure it has resources available to invest in operational activities designed to generate future income.  These resources were represented by £9,158,000 of cash and fixed term deposits as at 31 December 2018 (2017: £8,363,000)

 

5.     Revenue reporting

The Group is organised and operates as one segment. The Group's revenue analysed by geographical location of the Group's customers is:

 

      Year ended

    31 December

                  2018

      Year ended

    31 December

                  2017

 

                      £

                      £

Middle East / ROW

                       -

              12,727

United States of America

                       -

                      -

Europe

                       -

            350,000

 

     -

           362,727

 

 

6.     Operating loss

 

  Year ended

   31 December

              2018

  Year ended

   31 December

              2017

Operating loss is stated after charging:

 

£

£

Depreciation of plant and equipment (note 12)

                19,850

               13,248

Loss on disposal of plant and equipment

703

-

Inventories consumed in R&D

                62,633

               22,978

Operating lease costs: property

              114,142

              116,076

Loss on foreign exchange

                12,606

                  9,701

 

 

 

6.    Operating loss (continued)

 

The fees of the Group's auditor KPMG LLP for services provided are analysed below:

 

  Year ended

   31 December

              2018

  Year ended

   31 December

              2017

Audit services

£

£

Parent company

33,000

26,000

Subsidiaries

9,000

7,500

Tax services

 

 

Parent company

                  4,000

2,500

Subsidiaries

                        -

1,000

Total fees

46,000

37,000

 

 

7.     Staff numbers and costs

 

The average number of persons (including all Executive and excluding Non-Executive Directors) employed by the Group during the year, analysed by category, was as follows:

 

     Year ended

    31 December

                  2018

     Year ended

    31 December

                  2017

R&D staff

           10

           8

Finance and Administration staff

              2

              3

Executive Directors

               3

              3

 

15

14

 

The aggregate payroll costs of these persons were as follows:

 

     Year ended

    31 December

                  2018

      Year ended

      31 December

                    2017

 

                     £

                    £

Wages and salaries

           1,603,513

           1,584,122

Social security costs

              172,805

              200,623

Other pension and insurance benefits costs

              182,282

              168,131

Total cash-settled emoluments

           1,958,600

           1,952,876

Share-based payment remuneration charge

              146,833

              201,261

Total emoluments

           2,105,433

           2,154,137

 

All employees of the Group are employed by Futura Medical Developments Limited.

 

 

8.     Directors' emoluments

 

 Year ended

   31 December

              2018

 Year ended

   31 December

              2017

 

£

£

Aggregate emoluments

929,608

698,837

Other pension and insurance benefit costs

19,748

21,875

Subtotal per remuneration report

949,356

720,712

Share-based payment remuneration charge

74,647

97,967

Employer's national insurance charge

86,991

96,038

Total emoluments

1,110,994

              914,717

 

In 2018 one Director exercised share options under the Group share option schemes and realised a gain of £6,000 (2017: £28,768). In respect of the highest paid Director the realised gain was £nil (2017: £14,263).

 

In 2018 there were no Directors (2017: one Director) who participated in a private money purchase defined contribution pension scheme. Emoluments for individual Directors are disclosed within the Remuneration Report.

 

Emoluments above include the following amounts in respect of the highest paid Director:

Year ended

   31 December

              2018

  Year ended

   31 December

              2017

 

£

£

Aggregate emoluments

273,855

235,002

Employer pension contributions

-

-

Subtotal per remuneration report

273,855

235,002

Share-based payment remuneration charge

28,711

40,608

Employer's national insurance charge

36,284

32,176

Total emoluments

             338,850

              307,786

         

 

 

9.     Finance income

 

Interest receivable in 2018 on treasury funds was £27,576 (2017: £19,316).

 

 

 

10.   Taxation

 

10.1 Current tax

 

     Year ended

   31 December

                 2018

     Year ended

31 December

2017

 

                       £

                       £

UK corporation tax credit on loss on ordinary activities

          1,358,336

              936,344

 

 

The tax assessed for the year was lower than the UK corporation tax rate (2017: higher).  The differences are explained below:

 

 

 

 

 

Year ended

31 December

2018

     Year ended

   31 December

                2017

 

£

       £

Loss on ordinary activities before tax

7,238,912

 4,836,628

Loss on ordinary activities at an average standard rate of corporation tax in the UK of 19.00% (2017: 19.25%)

1,375,393

      931,051

Expenses not deductible for tax purposes                                                    

(215)

     (249)

Unrecognised deferred tax

(29,578)

             (30,523)

Unutilised tax losses

(581,892)

           (381,446)

Share scheme deduction         

5,529

    11,235

R&D expenditure credit

(3,296)

-

Loss surrendered for refund

(417,236)

-

Additional relief for R&D claims

995,722

            381,880

UK corporation tax credit

1,344,427

            911,948

Adjustment to tax charge relating to prior period

(144)

-

R&D expenditure credit re 2016

 

              9,098

R&D expenditure credit re 2017

 

15,298

R&D expenditure credit re 2018

14,053

              -

UK corporation tax credit reported in the

Consolidated Statement of Comprehensive Income

1,358,336

936,344

       

 

The Group has tax losses of approximately £26,834,483 (2017: £24,300,530) available for offset against future taxable profits.

 

The corporation tax credit for the year represents research and development tax credits of £1,344,427, arising from the surrender of losses (rather than carrying forward to future years) of £9,271,916 at 14.5%, under HMRC's small and medium size enterprise scheme. The taxable loss for the year is in excess of the accounting loss for various reasons, principally the additional deductions given for tax purposes on research and development expenditure.

 

10.  Taxation (continued)

 

In addition a small claim under the large company Research and Development Expenditure Credit (RDEC) scheme resulted in a refund of £14,053.

 

10.2 Deferred tax

Deferred tax assets amounting to £4,881,640 (2017: £4,133,675) have not been recognised due to it not being probable that taxable profits will be available, against which these deductible temporary differences can be utilised.  Reductions in the UK corporation tax rate from 20% to 19% (effective from 1 April 2017) and to 18% (effective from 1 April 2020) were substantively enacted on 26 October 2015, and an additional reduction to 17% (effective from 1 April 2020) was substantively enacted on 6 September 2016. The unrecognised deferred tax asset at 31 December 2018 has been calculated assuming a prevailing tax rate when the timing differences reverse of 17% (2017: 17%) and comprises:

 

 

      Year ended

    31 December

                  2018

      Year ended

    31 December

                  2017

 

                      £

                      £

Depreciation differential versus capital allowances

2,108

                  (348)

Other short-term timing differences

            317,670

               2,932

Unutilised tax losses

        4,561,862

        4,131,091

 

        4,881,640

        4,133,675

 

11.   Loss per share

 

The calculation of basic and diluted earnings per share ("EPS") is based on the following data:

      2018

   

2017

Earnings for the purposes of basic EPS and diluted EPS (£)

5,880,576

3,900,284

Weighted average of ordinary shares for purposes of basic and diluted EPS (number)

 

131,936,761

 

120,631,242

Loss per share basic and diluted (pence)

        4.46

        3.23

 

 

 

         

 

Diluted EPS is calculated in the same way as basic EPS but also with reference to reflect the dilutive effect of share options in existence at the year end which were 5,700,000 (2017: 6,507,000).  The diluted loss per share is identical to the basic loss per share, as potential dilutive shares are not treated as dilutive since they would reduce the loss per share.

 

12.   Plant and equipment

 

 

Computer Equipment   

Furniture

 and Fittings

 

  Total

Cost

£

£

£

At 1 January 2018

                 91,243

           63,285

          154,528

Additions

                4,510

           -    

              4,510

Disposals

               (9,151)

           -    

            (9,151)

At 31 December 2018

             86,602

        63,285

         149,887

Depreciation

 

 

 

At 1 January 2018

                37,915

            53,096

           91,011

Eliminated on disposals

               (8,447)

                        -

           (8,447)

Charge for year

             18,027

              1,823

           19,850

At 31 December 2018

             47,495

         54,919

          102,414

Net book value

 

 

 

At 31 December 2018

               39,107

           8,366

          47,473

At 31 December 2017

                53,328

            10,189

           63,517

 

 

 

 

Computer Equipment   

Furniture

 and Fittings

 

Total

Cost

£

£

£

At 1 January 2017

                  49.694

           60,787

         110,481

Additions

                  51,345

            4,249   

             55,594

Disposals

                 (9,796)

           (1,751)

            (11,547)

At 31 December 2017

                91,243

           63,285

          154,528

Depreciation

 

 

 

At 1 January 2017

                35,970

            53,160

             89,130

Eliminated on disposals

                (9,796)

             (1,751)

           (11,547)

Charge for year

                11,741

              1,687

             13,428

At 31 December 2017

                37,915

            53,096

           91,011

Net book value

 

 

 

At 31 December 2017

                53,328

             10,189

           63,517

At 31 December 2016

                  13,724

              7,627

            21,351

 

 

All fixed assets of the Group are held in Futura Medical Developments Limited.

 

 

13.   Inventories

 

31 December

         2018

31 December

         2017

 

              £

              £

Consumable materials used for development

 7,780

70,413

 

 

14.   Financial instruments by category

 

The accounting policies for financial instruments have been applied to the line items below:

 

Assets as per Consolidated Statement of Financial Position

31 December

         2018

31 December

         2017

 Loans and receivables at amortised cost

                     £

                     £

Trade and other receivables (note 15)

248,426

39,520

Cash and cash equivalents (note 16)

9,157,916

8,362,646

Total receivables

9,406,342

8,402,166

 

 

  31 December

               2018

  31 December

               2017

Liabilities as per Consolidated Statement of Financial Position at amortised cost

                      £

                      £

Trade and other payables (note 17)

1,246,247

131,430

 Total Payables

       1,246,247

    131,430

 

The Directors consider that there is no material difference between the carrying values of financial assets and liabilities, and their fair value.

 

 

15.   Trade and other receivables

 

 

31 December

         2018

31 December

         2017

Amounts receivable within one year:

              £

              £

Trade receivables

627

6,299

Other receivables

247,799

33,221

Financial assets (note 14)

248,426

39,520

Prepayments

57,982

141,556

 

306,408

181,076

 

Trade and other receivables do not contain any impaired assets. The Group does not hold any collateral as security and the maximum exposure to credit risk at the Consolidated Statement of Financial Position date is the fair value of each class of receivable.

 

16.   Cash and cash equivalents

 

31 December

         2018

31 December

         2017

 

              £

              £

 Cash at bank and in hand

5,706,519

168,825

Sterling short-term money market funds

3,451,397

8,193,821

 

9,157,916

8,362,646

 

 

 

17.   Trade and other payables

 

 

31 December

         2018

31 December

         2017

 

              £

              £

 Trade payables

1,246,247

131,430

Social security and other taxes

42,684

131,771

Deferred Income

-

12,503

Accrued expenses

736,584

223,437

 

2,025,515

499,141

 

The increase in payables is reflective of the increase in research and development activities relating to the Phase 3 study commencement in the year.

 

18.   Share capital

 

Authorised

31 December

         2018

31 December

2017

31 December

         2018

 31 December

2017

 

Number

Number

              £

£

Ordinary shares of 0.2 pence each

500,000,000

500,000,000

1,000,000

1,000,000

 

Allotted, called up and fully paid

31 December

         2018

31 December

         2017

31 December

         2018

31 December

         2017

 

Number

Number

              £

              £

Ordinary shares of 0.2 pence each

204,583,439

120,696,002

409,167

241,392

 

 

The number of issued ordinary shares as at 1 January 2017 was 120,144,950. During the year ended 31 December 2017, the Company issued shares of 0.2 pence each as follows:

Month

 Reason for issue

Gross Consideration

£

   Shares Issued

Number

 

January 2017

Non-Executive Director award at 28.45 pence per share

        28,669

    100,770

 

January 2017

Option exercise at 40.50 pence per share

       155,100

    382,962

 

May 2017

Option exercise at 51.75 pence per share

         15,525

     30,000

December 2017

Non-Executive Director award at 57.50 pence per share

         21,459

     37,320

               

 

 

 

18.    Share capital (continued)

 

The number of issued ordinary shares as at 1 January 2018 was 120,696,002. During the year ended 31 December 2018, the Company issued shares of 0.2 pence with each ordinary share carrying the right to one vote as follows:

Month

Reason for issue

Gross Consideration

   Shares

Issued

 

 

£

  Number

January 2018

Option exercise at 30.00 pence per share

        24,000

   80,000

January 2018

Option exercise at 30.00 pence per share

       24,000

   80,000

May 2018

Option exercise at 30.00 pence per share

        45,000

 150,000

November 2018

Share placing at 7.00 pence per share

     5,600,000

 80,000,000

November 2018

Open Offer placing at 7.00 pence per share

    250,421

   3,577,437

 

 

 

5,943,421

       83,887,437

                 

 

Net proceeds received were £5,480,239 after costs of £463,182 were settled.

 

19.   Share options

 

At 31 December 2018, the number of ordinary shares of 0.2 pence each subject to share options granted under the Company's Approved and Unapproved Share Option Schemes were:

 

Exercise Price per Share

At 1

January 2018

  Options  Exercised

Options   Lapsed

Options   Granted

At 31 December  2018

 

Exercise Period           

   Pence

    Number

     Number

Number

   Number

    Number

1 October 2013 - 30 September 2018

     56.50

627,500

              -

(627,500)

              -

            -

1 October 2014 - 30 September 2019

     61.50

660,000

              -

 (350,000)

              -

310,000

1 October 2015 - 30 September 2020

     71.50

750,000

              -

 (130,000)

    -

620,000

1 October 2016 - 30 September 2021

     51.75

710,000

                  -

 (130,000)

             -

580,000

1 October 2017 - 30 September 2022

     30.00

1,060,000

    (310,000)

             -

             -

750,000

1 October 2018 - 30 September 2023

     57.50

1,260,000

             -

 (300,000)

             -

960,000

1 October 2019 - 30 September 2024

    30.50

1,440,000

             -

(300,000)

             -

1,140,000

1 October 2020 - 30 September 2025

     7.50

-

             -

             -

1,340,000

1,340,000

 

 

6,507,500

(310,000)

(1,837,500)

1,340,000

5,700,000

 

 

 

On 19 November 2018 share options over 1,340,000 new ordinary shares were granted to employees (including Executive Directors) at a price of 7.50. The options have a 2 year vesting period and the exercise period for these options is 1 October 2020 to 30 September 2025.

 

 

 

 

19.    Share options (continued)

 

The share options outstanding at 31 December 2018 represented 2.78% of the issued share capital as at that date (2017: 5.39%) and would generate additional funds of £2,159,300 (2017: £3,145,813) if fully exercised. The weighted average remaining life of the share options outstanding at 31 December 2018 was 52 months (2017: 52 months) with a weighted average remaining exercise price of 50.26 pence (2017: 48.34 pence).

 

The share options exercisable at 31 December 2018 totalled 3,220,200 (2017: 3,707,500) with an average exercise price of 51.28 pence (2017: 51.53 pence) and would have generated additional funds of £2,318,200 (2017: £1,910,613) if fully exercised.

 

The Group's share option scheme rules apply to 5,320,000 of the share options outstanding at 31 December 2018 (31 December 2017: 6,027,500) and include a rule regarding forfeiture of unexercised share options upon the cessation of employment (except in specific circumstances). 

 

Options have historically been issued to advisors under the unapproved scheme. Such options generally vest immediately and are exercisable between one and two years after grant, there were 380,000 share options outstanding to advisors at 31 December 2018 (31 December 2017: 480,000).

 

There were no market vesting conditions within the terms of the grant of the share options.

 

The Black-Scholes formula is the option pricing model applied to the grants of all share options made in respect of calculating the fair value of the share options. 

 

 

19.    Share options (continued)

 

Share based payments

 

 

Inputs to share option pricing model

31 December

              2018

31 December

              2017

31 December

              2017

 

 

 

 

Grant date

19 November

12 September

   13 January

Number of shares under option

      1,340,000

       1,440,000

      1,260,000

Share price as at date of grant

    6.95 pence

  30.50 pence

  57.50 pence

Option exercise price

    7.50 pence

  30.50 pence

  57.50 pence

Expected life of options: based on previous exercise history

          3 years

          3 years

          3 years

Expected volatility: based on median fluctuations over 3 years

          82.70%

          67.82%

          65.74%

Dividend yield: no dividends assumed

                 0%

                 0%

                 0%

Risk-free rate: yield on 3 year treasury stock as at date of grant

     0.84% p.a.

     0.31% p.a.

     0.30% p.a.

 

Outputs generated from share option pricing model

31 December

             2018

31 December

             2017

31 December

              2017

 

 

 

 

Fair value per share under option

           3.57p

          11.55p

           20.37p

Total expected charge over the vesting period

       £47,838

      £166,320

       £256,662

 

Recognised in Consolidated Statement

of Comprehensive Income

31 December

              2018

31 December

              2017

31 December

              2017

 

                    £

                    £

                   £

The share-based remuneration charge comprises:

 

 

 

Share-based payments - employees

              3,016

           24,648

         144,731

Share-based payments - consultants

                    -

                    -

                    -

Share-based payments

              3,016

           24,648

                  144,731

 

 

The total expense recognised for the year arising from share-based payments is as follows:

 

 

 

 

 

 31 December 2018

£

31 December 2017

£

 

 

 

 

Group equity-settled share based payment expense

 

 

 

146,833

201,261

 

 

20.   Pension costs

 

The pension charge represents contributions payable by the Group to independently administered funds which during the year ended 31 December 2018 amounted to £86,990 (2017: £141,992). Pension contributions payable in arrears at 31 December 2018, included in accrued expenses at the relevant Consolidated Statement of Financial Position date, totalled £6,183 (2017: £4,300).

 

21.   Commitments

 

At 31 December 2018 the Group had operating lease commitments in respect of property leases cancellable on one month's notice of £9,767 (2017: £9,767).

 

 

 

 

22.   Related party transactions

 

Related parties, as defined by IAS 24 'Related Party Disclosures', are the wholly owned subsidiary companies, Futura Medical Developments Limited, Futura Consumer Healthcare Limited and the Board. Transactions between the Company and the wholly owned subsidiary companies have been eliminated on consolidation and are not disclosed.

 

Key management compensation

The Directors represent the key management personnel. Details of their compensation and share options are given in note 8 and within the Remuneration Report.

 

 


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